Esophageal Cancer
Conditions
Keywords
esophageal cancer, immune checkpoint, PD-1, CRISPER, autologous cell infusion
Brief summary
This study will evaluate the safety of PD-1 knockout engineered T cells in treating advanced esophageal cancer. Blood or tissue samples will also be collected for research purposes.
Detailed description
This is a prospective clinical study of ex-vivo selected, engineered, and expanded PD-1 knockout T cells from autologous origin. 16 advanced esophageal cancer patients are planned to receive two cycles of PD-1 knockout engineered T cells infusion. Immunological markers are analyzed as well.
Interventions
Programmed cell death 1(PD-1) gene will be knocked out by CRISPR Cas9
Sponsors
Anhui Kedgene Biotechnology Co.,Ltd
Hangzhou Cancer Hospital
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Masking description
open-label
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
* Histologically confirmed recurrent or metastatic esophageal cancer * Measurable disease * Progressed after standard treatments * ECOG performance status of 0-2 * Expected life span: \>= 3 months * Toxicities from prior treatment has resolved or ≤ grade 1 * Major organs function normally * Women at pregnant ages should be under contraception * Willing and able to provide informed consent
Exclusion criteria
* Other malignancy within 5 years prior to entry into the study, expect for treated non-melanoma skin cancer and cervical carcinoma in situ * Poor vasculature * Disease to the central nervous system * Blood-borne infectious disease, e.g. hepatitis B * History of mandatory custody because of psychosis or other psychological disease inappropriate for treatment deemed by treating physician * With other immune diseases, or chronic use of immunosuppressants or steroids * Pregnancy (women of childbearing potential:Refusal or inability to use effective means of contraception) * Breastfeeding * Decision of unsuitableness by principal investigator or physician-in-charge
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Response Rate | 1-3 months | Response will be evaluated according to RECIST v1.1 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of Treatment-Emergent Adverse Events | 6 months | Number of participants with Adverse Events and grade as a measure of safety and tolerability of PD-1 knockout T cells using CTCAE v4.03 |
Other
| Measure | Time frame | Description |
|---|---|---|
| Progression free survival (PFS) | 1 year | From date of randomization until the date of first documented progression or date of death from any cause |
| Overall Survival (OS) | 1 year | The time from randomization to death from any cause |
| Peripheral blood T lymphocyte subsets | 6 weeks | Sera were collected at baseline and after the first cycle to measure T lymphocyte subsets with flow cytometry |
| Tumor-infiltrating T cells | Baseline and after treatment | Baseline and post-treatment tissue samples were tested for the tumor-infiltrating T cells with immunofluorescence. |
Countries
China
Outcome results
None listed